NCT03912792

Withdrawn

A Cross-Sectional Natural History Study to Evaluate Sweat Vo...

Dermelix Biotherapeutics, LLC.Source

Dermelix Biotherapeutics, LLC.

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

DMX101-0001

Study Type

observational

Actual enrollment (reported)

0

Locations

1 country

Sites

1

Timeline

Study Start

June 28, 2019

Actual (reported)

Primary Completion

September 2019

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

September 2019

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

The proposed natural history study will enroll male patients with a diagnosis of XLHED, female carriers of XLHED and healthy volunteers. The study protocol will include collection of XLHED questionnaires and clinical outcomes using minimally invasive technologies. Data will be collected both retrospectively and prospectively. Clinical outcome assessments will be performed at the NFED Family Conference on July 11-12, 2019. Study participants will be able to complete XLHED questionnaires electronically ahead of the conference.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: withdrawn
Actual enrollment (reported): 0 participants
Study completion date: September 2019
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
April 10, 2019
Actual (reported)
First Posted
April 11, 2019
Actual (reported)
Study Start
June 28, 2019
Actual (reported)
Primary Completion
September 2019
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2019
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: July 2, 2019
Status Verified: June 2019
Last Update Submitted: June 28, 2019

Conditions

XLHED

Keywords

Natural History StudyX-Linked Hypohidrotic Ectodermal Dysplasia

Outcome Measures

Primary Outcomes (1)

The volume of sweat from a pilocarpine-induced sweat test
Day 1

Study Arms (2)

XLHED Patients

Healthy Controls

Eligibility Criteria

AgeUp to 80 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Males with XLHED and female carriers of XLHED Male and female healthy volunteers

You may qualify if:

Informed Consent

Sponsors & Collaborators

Dermelix Biotherapeutics, LLC.
Industrylead

Study Sites (1)

Chicago Marriott Lincolnshire Resort

Lincolnshire, Illinois, 60069, United States

MeSH Terms

Conditions

Ectodermal Dysplasia 1, Anhidrotic

Condition Hierarchy (Ancestors)

Ectodermal DysplasiaAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin AbnormalitiesGenetic Diseases, X-LinkedGenetic Diseases, InbornSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Dorothy K Grange, MD
Washington University School of Medicine
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: OTHER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 10, 2019

First Posted

April 11, 2019

Study Start

June 28, 2019

Actual (reported)

Males with XLHED, female carriers of XLHED and healthy volunteers

You may not qualify if:

Treatment with an investigational study drug for XLHED
Any major medical problems that would prevent her/him from participating in this study
Known hypersensitivity to pilocarpine or pilocarpine-like muscarinic agonists (Examples: Urecholine, Salagen, Pilocar, and Provocholine)
Pacemaker

Contact the study team to confirm eligibility.

Primary Completion

September 2019

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

September 2019

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

July 2, 2019

Record last verified: 2019-06

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03912792
Data provider: ClinicalTrials.gov
Source updated: 2019-07-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:12 UTC

Locations

US(1)

Study Stopped

A Cross-Sectional Natural History Study to Evaluate Sweat Volume and Other Phenotypic and Genetic Characteristics in Patients Affected by XLHED

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

XLHED Patients

Healthy Controls

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

XLHED Patients

Healthy Controls

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations